Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach
|Attention Deficit Hyperactivity Disorder ADHD||Other: fMRI scans Drug: Atomoxetine arm Drug: Methylphenidate arm||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach|
- Brain Activation [ Time Frame: Baseline and at 6 - 8 weeks ]
Comparison of brain activation at 6-8 weeks changed from baseline.
a) 'Task-positive' regions; b) 'Task-negative' regions; c) 'Task-positive' regions and 'task-negative' regions;d) Normalization of reduced connectivity; e) Compensatory increases in functional connectivity
- Go-Nogo [ Time Frame: Baseline and at 6-8 weeks ]Comparison of Go-Nogo at 6-8 weeks changed from baseline. Performance on a go-nogo task inside the scanner
- ADHD-RS [ Time Frame: up to 8 weeks ]behavioral symptoms of ADHD
- Clinical Global Impressions-Severity (CGI-S) [ Time Frame: up to 6 weeks ]a clinician rated measure of symptom severity
- Change in Attention Networks Test (ANT) [ Time Frame: baseline and at 6 weeks ]A neuropsychological assessment of attention compared at 6 weeks from baseline
- Continuous Performance Test (CPT) [ Time Frame: baseline and at 6 weeks ]A neuropsychological assessment of attention compared at 6 weeks from baseline
- Finger Windows [ Time Frame: baseline and at 6 weeks ]A neuropsychological measure of motor skill and visual-spatial working memory compared at 6 weeks from baseline
- Digit Span [ Time Frame: baseline and at 6 weeks ]A cognitive/neuropsychological measure of auditory/verbal working memory compared at 6 weeks from baseline
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Active Comparator: fMRI scans
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
Other: fMRI scans
2 fMRI scans 6-8 weeks apart
Experimental: Atomoxetine arm
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
Other: fMRI scans
2 fMRI scans 6-8 weeks apartDrug: Atomoxetine arm
Flexible dose titration with atomoxetine prescribed at weekly visits for 6-8 weeks
Experimental: Methylphenidate arm
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
Other: fMRI scans
2 fMRI scans 6-8 weeks apartDrug: Methylphenidate arm
Flexible dose titration with methylphenidate for 6-8 weeks, with optional post study stabilization visits.
The specific aims of this project are to use functional magnetic resonance imaging (fMRI) to determine the significance of activation changes over treatment related to clinical improvement, and the impact of treatment on neural connectivity within and between the anti-correlated frontostriatal 'task-positive' circuit and cingulate-precuneus 'task-negative' network. Our central hypotheses are that clinical improvement is associated with: (i) normalization of reduced connectivity of regions within the 'task-positive' network, with resultant increased inhibition of motor cortex, and (ii) normalization of low task-related connectivity in regions within the task-negative network for MPH and the 'task-positive' network for ATX.
This research proposes to test a model which posits a neurophysiological basis of mechanisms of response to stimulant and non-stimulant medications, and fits with our long term objectives of being able to match treatments to individual patients. Testing this model requires large samples of youth scanned using fMRI before and after treatment, and matched healthy controls also scanned twice. We will use an innovative network-based approach to study the effects of treatment, building on results from our current fMRI treatment study, and incorporating new theoretical approaches to understanding ADHD and its treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678209
|Contact: Beth Krone, PhD||212-241-8012||Beth.Krone@mssm.edu|
|Contact: Erica Pazminofirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Jeffrey Newcorn, MD|
|Principal Investigator: Kurt Schulz, PhD|
|Principal Investigator:||Jeffrey Newcorn, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Kurt Schulz, PhD||Icahn School of Medicine at Mount Sinai|